As the global hemp industry continues to mature, the rules and regulations that encompass the space are constantly evolving. Hemp businesses preparing for success and scaling for future growth have a variety of best practices to consider, but one set of regulations becoming increasingly important in the early stages is current good manufacturing practices (cGMPs or GMPs). GMPs are the rules and regulations that ensure the quality, safety, and efficacy of food or pharmaceutical products by addressing all aspects of the production process. GMP certification is becoming paramount for hemp extraction facilities looking to remain competitive and align with international industry standards. This column discusses some of the most important considerations involved in the GMP certification process.
The Owner, Architect, and Engineer Triad
Ultimately, the responsibility of understanding and integrating the above list of topics into a comprehensive manufacturing, quality management, and cGMP certification scheme (supported by a hemp-centric business model) is the responsibility of the facility owner or senior management. To facilitate this, process owners and senior management should enlist the help of a qualified support team to help lead facility design. This support team will likely involve the owner and their team of staff that will be overseeing or operating the facility, a GMP consultant to guide the owner through the cGMP requirements and certifications, and a design team consisting of an architect, qualification and validation engineers, and mechanical, electrical, and plumbing (MEP) engineers. It is incredibly important that this complete team of experts is engaged early and often—proper coordination is key to success.
The Architect’s Role in the Design of a cGMP Facility
Architects are professionally licensed and specialize in designing the architectural components of a facility. While there are architects with more cGMP experience than others, it is ultimately the owner’s responsibility to be sure that the architect is aware of the cGMP requirements that will fall under the architect’s scope. While the architect will not direct the cGMP requirements, it is important to collaborate with an architect with design expertise in cGMP facilities. Note that oftentimes, the architect may hold the contract for the entire engineering team as well, so it will be important to define all requirements for the entire design team. Though they will vary from project to project, a few simple examples of items that the GMP consultant and owner may need to define for the architecture team are discussed in more detail below.
Product Quality Attributes and Critical Process and Facility Parameters
In the design of a GMP facility, all attributes of design and installation are focused on the mitigation of product contamination, the conduct of robust and routine product manufacture, and the safety and efficiency of operations. The conduct of risk analyses drive key considerations, which must be outlined for the architect upfront, driving fundamental aspects of facility design to include airflows and pressurization schemes, materials of construction, and equipment requirements (explored further below). During validation master-planning, a predefined set of criteria will be established to demonstrate conformance with the cGMPs, many of which influence the basis of design and installation of equipment critical to the architect and MEP engineers, with the goal of ultimately establishing cGMP conformance.
Requirements for Easily Cleanable Walls, Floors, and Ceilings
This may include fiberglass reinforced plastic (FRP), stainless steel, or polyvinyl chloride (PVC) walls and ceilings; epoxied floors, and coved bases between the wall and floor to create an impervious seal between the intersection of these two surfaces, making them easier to clean and maintain. Note: pay special attention to static charge that may build on these surfaces in classified areas containing flammable or explosive materials and operations, and work with your architect to select the best materials to meet your needs.
Personnel Flow and Gowning Requirements
The owner will need to explain the personnel flow and gowning requirements of the facility so that the architect can take this into consideration when space planning.
Airlock or Vestibule Requirements Between Corridors and Process Rooms
These spaces are explained in more detail under the heating, ventilation, and air conditioning (HVAC) section below. The architect will need to know where airlocks are required so that they can factor them into space planning.
The Engineer’s Role in the Design of a cGMP Facility
MEP engineers are professionally licensed with expertise in designing a facility’s mechanical (HVAC), electrical, and plumbing systems. MEP systems are not the manufacturing process, they are the support systems that breathe life into the manufacturing process. As a very simple definition, these systems provide energy, create the environment within which the process lives, and remove waste. It’s important to recognize that while these engineers have deep expertise in their fields, the focus of their roles and expertise is not necessarily to direct the cGMP specifications, but to create systems that meet the requirements of your cGMP specifications. As mentioned previously, the owner is responsible for determining what standards the engineers should design to. A GMP consultant can assist with this process and communication. As is true for the architecture team, while the engineering team will not direct the cGMP requirements, it is important to work with an engineering team with design expertise in cGMP facilities. Though they will vary from project to project, a few simple examples of items that the GMP consultant and owner may need to define for the engineering team include the following items described below.
ISO classes of cleanroom vary from ISO 1 (extremely clean) to ISO 9 (clean) (see Table I). There are many requirements for each clean room class including air change rates, filter types, and filter coverage that will impact costs associated with each class. ISO 7 classification is often observed in hemp facilities, but it is the owner’s responsibility to determine the appropriate cleanroom class and convey the cleanroom class to their designers, based on information they have received from their GMP consultant. Designers can then meet the design requirements for the cleanroom class expected.
You will have specific equipment that you have selected for your process. It is important that your engineers receive this information prior to beginning their design, and that the information is complete and accurate. Inaccuracies will result in extra design time and money spent.
Temperature and Humidity Requirements
While the HVAC system can ensure that the temperature and humidity requirements are met, the engineering team expects that the owner will provide these requirements.
- A. Gasparro, The Wall Street Journal, January 9, 2020, https://www.wsj.com/articles/cloudy-regulation-slows-cbds-seep-into-food-and-drinks-11578574807.
- M. Gauthier, HealthMJ, January 2020, https://www.healthmj.com/cbd/hemp-cbd-bubble-prices-market-growth/.
- V. Rees, European Pharmaceutical Review, August 2019, https://www.europeanpharmaceuticalreview.com/article/96609/cannabinoids-in-pharma-series-cannabinoids-on-the-market-today.
- U.S. Food and Drug Administration, Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements, https://www.fda.gov/food/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements.
- Electronic Code of Federal Regulations, https://www.ecfr.gov/cgi-bin/text-idx?SID=3f7125891958b3eb9380856f26065b5c&mc=true&node=pt21.2.117&rgn=div5.
- A. Bhatia, HVAC Design for Pharmaceutical Facilities (Continuing Education and Development, Inc., Stony Point, New York) https://www.cedengineering.com/userfiles/HVAC%20Design%20for%20Pharmaceutical%20Facilities.pdf.
About the Columnists
Laura J. Breit, PE, is the founder and owner of Oregon-based firms Root Engineers and Cole-Breit Engineering. She is a professional mechanical engineer specializing in the design of HVAC, plumbing, and process systems for the cannabis industry. Since legalization in her home state of Oregon in 2014, Laura has led her team of mechanical and electrical engineers and designers on more than 100 cannabis-related projects across the country.
Jeffrey F. Breit, PhD, has more than 15 years of experience leading program development efforts for pharmaceutical and health and nutrition products. He has played a leading role in the development of both organic and cGMP compliant manufacturing facilities and processes.
How to Cite this Article
L.J. Breit and J.F. Breit, Cannabis Science and Technology 3(2), 16–20 (2020).